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The Trifecta (TM) Valve. (Photo: St. Jude Medical, Inc.) Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta ...
[31] [32] It was the first aortic valve device to receive FDA approval, in November 2011 for use in inoperable patients and in October 2012 for use in patients at high surgical risk. [33] The device is effective in improving functioning in patients with severe aortic stenosis.
In 2021, FDA restricted use of Ocaliva to PBC patients who did not have advanced cirrhosis or severe scarring of the liver. US FDA staff questions confirmatory trial data for Intercept's liver ...
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.
Endobronchial valves are medical devices that allow air to exit these sections but not to re-enter. The valves, in effect, cause damaged lung tissue to deflate, thereby reducing the excessive lung volume (hyperinflation) caused by emphysema. Two endobronchial valves have been approved by the FDA for BLVR: Zephyr and Spiration. [citation needed]
(Reuters) -Abbott Laboratories said on Tuesday the U.S. FDA has approved its heart valve repair device for patients with a potentially fatal heart disease, just months after rival Edwards ...
Cannon A wave. Cannon A waves, or cannon atrial waves, are waves seen occasionally in the jugular vein of humans with certain cardiac arrhythmias.When the atria and ventricles happen to contract simultaneously, the right atrium contracts against a closed tricuspid valve, resulting in back pressure into the venous system that can be seen in the jugular venous pulse as a high-amplitude "cannon ...
The drug, an antibody-drug conjugate (ADC), was being studied in a trial sponsored by China-based MediLink, in patients with types of non-small cell lung cancer or breast BioNTech says FDA lifts ...